AxitinibInlyta
Second-line treatment of stage IV clear cell variant renal cell carcinoma (RCC) in patients with progressive disease following first-line tyrosine kinase inhibitor treatment.
Decisions on record
- Meeting Nov 2014 Recommended tablets, 1 mg & 5 mg, Inlyta® Pfizer Australia Pty Ltd New listing (Major submission) Renal cell carcinoma Authority Required listing for the treatment of Stage IV clear cell variant renal cell carcinoma in patients meeting certain criteria.
- Meeting Nov 2013 Not recommended 1 mg and 5 mg, tablet Pfizer Australia Pty Ltd Renal cell carcinoma (RCC) Authority Required listing for the treatment of Stage IV clear cell variant renal cell carcinoma (RCC) in a patient who meets certain criteria. Because the claim of clinical efficacy was not substantiated by the data presented
Access path
- TGA registered · Inlyta
TGA label narrower than the PBS population
- Nov 2013Not recommended
inadequate data to support claim of superior clinical effectiveness over best supportive care, indirect comparison not…
- ↻ resubmittedNov 2014Recommended · restricted
Comparator changed: best supportive care → everolimus
- PBS listing · Authority Required
From the public summary
7.1 The PBAC recommended listing axitinib as an Authority Required benefit for the treatment of Stage IV clear cell variant RCC in a patient with a WHO performance status of 2 or less, after failure of prior PBS-subsidised first-line treatment for this condition, on a cost-minimisation basis with everolimus. The equi-effective doses are axitinib 5 mg twice daily and everolimus 10 mg once daily.PSD · Nov 2014
7.2 The PBAC recalled that it had previously rejected a submission in November 2013 seeking second-line treatment of Stage IV clear cell RCC on the basis of inadequate data to support the claim of superior clinical effectiveness over best supportive care (BSC).PSD · Nov 2014
6.18 A cost-minimisation analysis of axitinib versus everolimus was presented.PSD · Nov 2014
6.19 The re-submission’s proposed equi-effective doses were axitinib 5 mg twice daily and everolimus 10 mg once daily.PSD · Nov 2014
6.17 The re-submission described axitinib as non-inferior in terms of comparative effectiveness and non-inferior in terms of comparative safety over everolimus. The ESC considered that the evidence presented in the re-submission was insufficient to support the claim.PSD · Nov 2014
For more detail on PBAC’s view, see section 7 “PBAC outcome”PSD · Nov 2014
6.2 The PBAC noted and welcomed the input from individuals (6) and organisations (1) via the Consumer Comments facility on the PBS website. The comments described a range of benefits of treatment with axitinib including a clinical need for having alternative second line drug made available for the treatment of RCC.PSD · Nov 2014
For more detail on PBAC’s view, see section 7 “PBAC outcome”PSD · Nov 2014
Cost-effectiveness
ICER not stated in the PSD. Economic modelling was not conducted as the submission was based on indirect comparison of PFS and OS outcomes.
Since the claim of clinical efficacy was not substantiated by the data presented, the PBAC did not find the economic modelling to be valid or informative. PBAC · 2014
Decision context
PopulationAdults with stage IV clear cell variant renal cell carcinoma with progressive disease according to RECIST following first-line treatment with a tyrosine kinase inhibitor, with WHO performance status of 2 or less.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Nov 2014 | Recommended · restricted | everolimus | — | RCT · PFS |
| Nov 2013 | Not recommended | best supportive care | $45k–75k | RCT · OS |
Consumer voice
Six individuals and Kidney Health Australia provided input supporting axitinib as an alternative second-line treatment for renal cell carcinoma, noting the clinical need for more PBS-subsidised options and advocating for improved treatment sequencing with multiple tyrosine kinase inhibitors.
The comments described a range of benefits of treatment with axitinib including a clinical need for having alternative second line drug made available for the treatment of RCC. Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to clear cell variant, stage IV, progressive disease post-TKI, and WHO performance status ≤2; TGA label is broader.